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CTRI Number  CTRI/2021/09/036404 [Registered on: 10/09/2021] Trial Registered Prospectively
Last Modified On: 09/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Lepa and Virechan]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   KITIBHA KUSTHA (PSORIASIS) AND ITS MANAGEMENT THROUGH AYURVEDA 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY OF HARITKYADI CHURNA VIRECHAN AND JIVANTYADI LEPAM IN KITIBHA KUSTHA (PSORIASIS). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gourishankar Rajpurohit 
Designation  MD Scholar 
Affiliation  UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur 
Address  PG Department of Panchkarma UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9799599847  
Fax    
Email  gouri.raj728@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahesh Kumar Sharma 
Designation  Professor & H.O.D 
Affiliation  UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur 
Address  PG Department of Panchkarma UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9829695452  
Fax    
Email  drmksharma2016@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gourishankar Rajpurohit 
Designation  MD Scholar 
Affiliation  UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur 
Address  PG Department of Panchkarma UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9799599847  
Fax    
Email  gouri.raj728@gmail.com  
 
Source of Monetary or Material Support  
UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur 
 
Primary Sponsor  
Name  UCA Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 
Address  UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gourishankar Rajpurohit  Hospital of University College of Ayurveda  PG Department of Panchkarma, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur
Jodhpur
RAJASTHAN 		 9799599847

gouri.raj728@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: KITIBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charak Samhita, Procedure details: Virechan with Haritkyadi churna )
(1) Medicine Name: Haritkyadi churna, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 15 Days
2Intervention ArmProcedure-lepa, लेप (Procedure Reference: Ashtang Hridayam, Procedure details: Jivantyadi lepa will be applied once in a day for 30 days )
(1) Medicine Name: jivantyadi lepa, Reference: Ashtang Hridayam, Route: Topical, Dosage Form: Lepa Churna, Dose: 15(g), Frequency: od, Duration: 30 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed and Confirmed case of Kitibha Kushtha (Psoriasis), between the age of 18 years to 60 years and who are clinically fit for Shodhana karma will be included in this trial. 
 
ExclusionCriteria 
Details  If Patient having Malignancy or are not applicable in age criteria will be excluded. Also If patient is going through another treatment will be excluded. Lactating and Pregnant women will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in Symptoms of Kitibh Kushtha (psoriasis)  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of the comparative efficacy of treatment in both groups.  30 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/09/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Kitibha Kushtha (Psoriasis) is common and chronic skin disorder. In this trial two group will be made and Group A will be applied with Haritkyadi Churna Virechana 10 gm OD and Group B will be applied with Jivantyadi Lepam OD both for 30 days. The subjective and Objective criteria will be measured in the end of treatment and result for both groups will be compared on behalf of their effcacy and relief and improvement in signs and symptoms of Kitibha Kushtha (Psoriasis).  
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